Director, GCP Quality Assurance
About The Position
Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. The Director, GCP Quality Assurance is responsible for providing strategic and operational Quality Assurance oversight for Good Clinical Practice (GCP) activities supporting the company’s clinical development programs. This role ensures that clinical trials are conducted in compliance with applicable regulatory requirements, company policies, and global GCP standards, with a continuous state of inspection readiness. The Director partners closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and external service providers to implement a risk-based quality oversight model across the clinical lifecycle. The role is accountable for GCP quality systems, vendor oversight, audits, and inspection support, and plays a critical role in embedding quality by design into clinical development programs
Requirements
- Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
- 10+ years of experience in GCP Quality Assurance or Clinical Quality within a biotech or pharmaceutical environment.
- Strong knowledge of global GCP regulations and clinical trial oversight requirements.
- Demonstrated experience supporting regulatory inspections and audits.
- Experience overseeing CROs and other GCP service providers.
- Experience supporting late-stage or pivotal clinical trials.
- Strong background in risk-based quality management and inspection readiness.
- Skilled at influencing without authority; effectively engages senior scientific, clinical, and operational stakeholders to drive alignment on quality priorities and shared accountability for compliance
- Able to serve as a primary quality representative in regulatory agency interactions and inspections, communicating the company's quality posture with confidence and credibility.
- Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue.
Responsibilities
- Develop and implement the GCP QA strategy aligned with clinical development objectives and global regulatory expectations
- Serve as a key QA partner to Clinical Operations and cross-functional stakeholders on GCP compliance and quality risk management.
- Promote a strong culture of quality, compliance, and continuous improvement across clinical programs
- Oversee GCP quality systems including deviations, investigations, CAPAs, change control, documentation, and training related to clinical activities.
- Ensure GCP processes are phase-appropriate, compliant, and scalable
- Support the development, review, and approval of GCP-related SOPs, policies, and work instructions.
- Provide QA oversight for GCP activities conducted internally and by CROs, vendors, and other service providers
- Lead GCP vendor qualification, audit strategy, and ongoing oversight using risk-based principles.
- Review and approve GCP-related quality agreements and vendor oversight plans
- Plan and execute risk-based GCP audits, including CRO audits, investigator site audits, and system audits as applicable.
- Lead GCP inspection readiness activities and serve as a primary QA contact during health authority inspections.
- Coordinate inspection preparation, conduct, and follow-up, including responses to regulatory observations.
- Ensure a sustainable state of inspection readiness across clinical programs.
- Ensure critical-to-quality considerations are embedded in clinical trial design and execution.
- Provide oversight of data integrity practices across GCP processes and systems.
- Identify, assess, and proactively mitigate GCP compliance risks
- Perform other duties and responsibilities as assigned
Benefits
- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule
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What This Job Offers
Job Type
Full-time
Career Level
Director
